News & Analysis as of

Pharmaceutical Benefits Scheme

Smart & Biggar

Rebate Update: Amendments to Ontario Regulations remove cap on Ordinary Commercial Term Benefits and restrictions on Private Label...

Smart & Biggar on

In November 2019, we highlighted the key proposed amendments to Regulations made under the Ontario Drug Benefit Act (ODBA) and the Drug Interchangeability and Dispensing Fee Act (DIDFA). The proposed amendments aim to reduce...more

Baker Donelson

HHS Proposes Removing Anti-Kickback Safe Harbor Protection for PBM Rebates, Proposes Two New Safe Harbors

Baker Donelson on

On January 31, the Department of Health and Human Services (HHS) and HHS Office of Inspector General (OIG) issued for public display a proposed regulation that would subject certain pharmaceutical manufacturer rebates paid to...more

Jones Day

Federal Court of Australia Grants First Interlocutory Injunction Against Biosimilar

Jones Day on

The Situation: Roche, the originator of the biologic therapy rituximab, sought interlocutory orders to restrain Sandoz from launching its rituximab biosimilar in Australia, on the basis that supply of the biosimilar would...more

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